Senior/Principal Scientist, LBA
Senior Scientist / Principal Investigator, Bioanalysis & Biomarkers
(GLP/GCLP · LBA · PK/ADA/Biomarkers)
Overview
A leading CRO is seeking an experienced bioanalytical scientist to join its Bioanalysis & Biomarkers group. This team supports global pharmaceutical and biotech partners by delivering high‑quality GLP/GCLP bioanalysis, method development, and biomarker services across both preclinical and clinical programs.
This role provides scientific leadership on regulated bioanalytical studies, acting as a key partner to clients and ensuring successful execution of PK, ADA (immunogenicity), and biomarker assays.
What You'll Do
- Design assay strategies and independently develop, validate, execute, and troubleshoot ligand‑binding bioanalytical methods (PK, ADA, biomarkers) under GLP/GCLP.
- Analyze, present, and interpret data for internal teams and external clients.
- Serve as the Principal Investigator, owning client interaction from study design and planning through execution, reporting, and data transfer.
- Ensure study timelines, deliverables, and quality expectations are consistently met.
- Act as Subject Matter Expert for LBA platforms, including ELISA multimode readers and Meso Scale Discovery (MSD/ECL).
- Write and/or review regulatory documents, validation protocols/reports, technical reports, and data packages.
- Provide day‑to‑day oversight of laboratory activities and mentor junior team members.
- Contribute to process improvements, operational excellence initiatives, and updates to SOPs, procedures, and work instructions.
- Maintain compliance with GLP/GCLP/GCP/GDP, EHS requirements, and organizational standards.
- Support additional responsibilities as needed.
What You Bring
- Degree in a relevant scientific field (Biology, Immunology, Chemistry, Pharmacology, or related).
- Ph.D.: 4+ years industry experience
- Master's: 9+ years
- Bachelor's: 12+ years
in Pharma/Biotech/CRO environments
- Strong hands‑on experience with GLP/GCLP bioanalysis.
- Demonstrated expertise in LBA method development and validation for PK, ADA, and PD biomarker assays.
- Significant experience with immunogenicity assay development, validation, and sample analysis is highly preferred.
- Familiarity with Watson LIMS and prior CRO experience are pluses.
- Proven leadership abilities-project oversight and/or people management.
- Ability to work independently with excellent attention to detail.
- Strong collaboration skills and the ability to meet timelines in a client‑focused environment.
- Excellent written and verbal communication.
FAQs
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